Phase 1 clinical study of highly purified natural killer (NK) cell infusion for patients with refractory digestive/gastrointestinal cancer to standard therapy
- Conditions
- refractory digestive/gastrointestinal cancer
- Registration Number
- JPRN-UMIN000007527
- Lead Sponsor
- Cancer ImmunoCell Regulation, Kyoto Prefectural Univercity of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1) Presence of uncontrolled infection 2) Hypersensitivity or autoimmune disease requiring treatments 3) Presence of severe comlications(malignant hypertension, congestive heart failure, severe coronary disease, history of myocardial infarction less than six months prior, pulmonary fibrosis or active interstitial pneumonitis) 4) Inappropriate patients for this study due to severe complications. 5) Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction. 6) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable. 7) Medical history of severe hypersensitivity. 8) Severe mental impairment 9) Pregnant or lactating women 10) Patient with HBV, HCV, HIV, HTLV-1 or syphilis infection 11) Inappropriate patients for study judged by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety
- Secondary Outcome Measures
Name Time Method anti-tumor effect